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The Starting Point

The institutional review and endorsement of clinical trial protocols to for-profit sponsors also requires a submission of a proposal to Sponsored Projects.  When participation in an Industry Sponsored Clinical Trial appears likely, submit to Sponsored Projects in Kuali Research the documents listed below. These documents are required to begin contract negotiation.

  • In Kuali Research, the clinical trial questions under the "Questions" tab, within the "Compliance" panel must be answered
  • Form 700-U Financial Disclosure for Principal Investigator and Co-Principal Investigator (original to be forwarded to Office of Research, Zot Code: 7600, 160 Aldrich Hall)- as of 9/7/21, no longer uploaded with the IRB Protocol Application
  • Draft Budget
  • Clinical Trial Protocol
  • Draft Clinical Trial Agreement (CTA) or Draft Contract, if provided by sponsor

To trigger the review of the contract, send an email notification to the SPA CT team, or-ctcontracts@uci.edu, and the Conflict of Interest team, coioc@research.uci.edu.  Use the "Link" function in KR PD to automatically generate a link to use when emailing the teams.  Please note that the COI review will not begin until the IRB protocol application for this clinical trial has been submitted.

While the contract or CTA negotiation process proceeds, the PI and study team should proceed with other required startup activities, including developing and negotiating the budget and submitting the IRB protocol application.

Investigators should notify their assigned Principal Contract Officer as soon as possible when initiating a clinical trial supported by a for-profit sponsor. The review of the proposal and negotiation of the clinical trial agreement requires time and cannot be left to the last minute.

Sponsored Projects can begin to negotiate a clinical trial agreement prior to IRB approval. However, the clinical trial cannot commence until the IRB approves the protocol and Sponsored Projects has signed the clinical trial agreement.


Helpful Tools


Clinical Trial Decision Tree

The clinical trial decision tree is a visual aid designed to help assess whether industry-funded studies qualify as clinical trials under the UC definition.

Investigator-Initiated Trials (IITs) Toolkit

IITs require special consideration in the planning stages. UC Braid's IITs toolkit provides guidance on starting up an IIT to facilitate efficient contracting and move the trial forward as quickly as possible.

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